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| Tracking Information | |||||
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| First Received Date ICMJE | July 16, 2002 | ||||
| Last Updated Date | July 17, 2009 | ||||
| Start Date ICMJE | January 2002 | ||||
| Primary Completion Date | February 2004 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Minimum joint space width in teh medial compartment of the tibiofemoral joint of the knee at one year [ Time Frame: One year ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00041756 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficacy and Safety of PG-530742 in the Treatment of Mild to Moderate Knee Osteoarthritis | ||||
| Official Title ICMJE | Efficacy and Safety of PG-530742 in the Treatment of Mild to Moderate Knee Osteoarthritis | ||||
| Brief Summary | Matrix metalloproteinases have been implicated in the cartilage degradation that occurs in osteoarthritis. PG-530742 inhibits some of these matrix metalloproteinases, thus potentially limiting cartilage degradation and disease progression. This study will test the efficacy and safety of PG-530742 in the treatment of mild to moderate knee osteoarthritis. |
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| Detailed Description | |||||
| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Osteoarthritis, Knee | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | Krzeski P, Buckland-Wright C, Bálint G, Cline GA, Stoner K, Lyon R, Beary J, Aronstein WS, Spector TD. Development of musculoskeletal toxicity without clear benefit after administration of PG-116800, a matrix metalloproteinase inhibitor, to patients with knee osteoarthritis: a randomized, 12-month, double-blind, placebo-controlled study. Arthritis Res Ther. 2007;9(5):R109. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 401 | ||||
| Completion Date | February 2004 | ||||
| Primary Completion Date | February 2004 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 40 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Hungary, United Kingdom | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00041756 | ||||
| Responsible Party | John Beary, MD, Procter and Gamble Pharmaceuticals | ||||
| Study ID Numbers ICMJE | 2001065 | ||||
| Study Sponsor ICMJE | Procter and Gamble | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Procter and Gamble | ||||
| Verification Date | July 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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